Bevacizumab, Docetaxel, and Gemcitabine Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

A Phase II Study of Bevacizumab Plus Docetaxel and Gemcitabine in Subjects With Advanced, Previously Untreated, Non-Squamous Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970684
• Other study ID #: CASE4507
• Secondary ID: P30CA043703CASE4
• Status: Completed
• Phase: Phase 2
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: July 2022
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with docetaxel and gemcitabine hydrochloride may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel and gemcitabine hydrochloride works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Description:

OBJECTIVES:

Primary

• Estimate the 1-year progression-free survival rate in patients with stage IIIB, stage IV, or recurrent non-squamous cell non-small cell lung cancer treated with bevacizumab, docetaxel, and gemcitabine hydrochloride.

Secondary

• Evaluate the median time to progression in patients treated with this regimen.

• Estimate the response rate in patients treated with this regimen.

• Determine the median overall survival of patients treated with this regimen.

• Determine the incidence of adverse events associated with this regimen in these patients.

OUTLINE: Patients receive bevacizumab IV over 30-90 minutes and docetaxel IV over 60 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease may then continue to receive bevacizumab alone for up to 12 months in the absence of disease progression.

After completion of study treatment, patients are followed up every 3 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed non-squamous cell non-small cell lung cancer

• Stage IIIB (with pleural effusion), stage IV, or recurrent disease

• Bidimensionally measurable disease

• No known CNS disease, except for previously treated brain metastasis defined as no evidence of progression or hemorrhage after treatment AND no ongoing requirement for dexamethasone as documented by clinical examination, MRI, or CT scan

• Treatment for brain metastases may have included whole brain radiotherapy, radiosurgery (gamma knife, LINAC, or equivalent), or a combination of therapy as deemed appropriate by the treating physician

• Stable dose of anticonvulsants allowed

• No known metastatic disease to the gastrointestinal tract (e.g., stomach, small bowel, or large bowel)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• Life expectancy > 3 months

• ANC = 1,500/mm^3

• Platelet count = 100,000/mm^3

• Hemoglobin = 9 g/dL

• Bilirubin = 2.0 mg/dL

• AST or ALT = 2.5 times upper limit of normal (ULN) (= 5.0 times ULN if hepatic metastases are present)

• Serum creatinine = 1.8 mg/dL

• Urine protein:creatinine ratio < 1.0 OR proteinuria < 2+ by urine dipstick OR = 1 g of protein by 24-hour urine collection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Available for regular follow-ups

• No inadequately controlled hypertension, defined as systolic BP > 150 mm Hg and/or diastolic BP > 100 mm Hg despite antihypertensive medications

• No history of hypertensive crisis or hypertensive encephalopathy

• No NYHA class II-IV congestive heart failure

• No myocardial infarction or unstable angina within the past 6 months

• No stroke or transient ischemic attack within the past 6 months

• No significant vascular disease (e.g., aortic aneurysm, aortic dissection requiring surgical repair, or recent peripheral arterial thrombosis) within the past 6 months

• No symptomatic peripheral vascular disease

• No evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)

• No history of colonic diverticular disease (i.e., diverticulosis or diverticulitis)

• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months

• No serious, nonhealing wound, ulcer, or bone fracture

• No known hypersensitivity to any component of bevacizumab

• No hemoptysis (bright red blood of = ½ teaspoon per episode) within the past 3 months

• No significant traumatic injury within the past 28 days

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior chemotherapy or biological therapy

• No prior radiotherapy to an area of measurable disease unless there is documented progressive disease after completion of therapy

• More than 2 weeks since prior radiotherapy

• More than 4 weeks since prior and no concurrent participation in another experimental drug study, except for a Genentech-sponsored bevacizumab cancer study

• More than 28 days since prior major surgical procedure or open biopsy

• More than 3 months since prior abdominal surgery

• More than 3 months since prior neurosurgical resection or brain biopsy

• More than 7 days since prior core biopsy or other minor surgical procedure, except placement of a vascular access device

• No concurrent major surgical procedure

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Biological:
• bevacizumab
15 mg/kg on day 1 of a 21-day cycle

Drug:
• docetaxel
75 mg/m2 on day 1
• gemcitabine hydrochloride
900 mg/m2 on days 1, and 8,

Locations

Country	Name	City	State
United States	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Fairview Hospital, Moll Pavilion	Cleveland	Ohio
United States	Hillcrest Hospital, a Cleveland Clinic Hospital	Mayfield Heights	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Nathan Pennell, MD, PhD	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival(PFS)	PFS is defined as time to death or first occurrence of documented disease progression assessed by the investigator as per the RECIST guidelines (at lease a 20% increase in the diameter of a lesion, in addition to an absolute increase of 5mm). If no deaths occur prior to progression, this measure will be the same as the median time to progression.	1 year
Secondary	Median Time to Progression	Time to progression (TTP) is defined as the time from start of treatment to first evidence of disease progression, defined per the RECIST 1.1 criteria as at least a 20% increase in the diameter of a lesion and an absolute increase of at least 5mm.	1 year
Secondary	Best Response	The number of patients with a response will be assessed using the RECIST criteria of complete response (the disappearance of all target lesions); partial response (at least a 30% decrease in the diameter of lesions); progressive disease at least a 20% increase in the diameter of lesions); or stable disease(neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease)	1 year